CTRI/2023/01/048837已完成未知
A Randomized, open-label, crossover, multicenter device usability study of Ciphaler™ versus Rotahaler® in patients with Asthma or Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Voluntarily given signed dated Informed consent from subjects.
- •2. Subjects of 18 years and above with history of asthma or COPD for more than 6 months prior to screening.
- •3. Subjects with asthma or COPD who are device naïve or those using BAI, pMDI or pMDI + spacer.
- •4. Subjects naïve to Ciphaler™ and Rotahaler® use.
- •5. Subjects naïve to any other DPIs for 6 months prior to screening.
- •6. Subjects able to read PIL.
排除标准
- •1. Subjects who are hypersensitive to placebo or its constituents.
- •2. Subjects with any condition that affected the subject’s ability to operate the inhaler such as cognitive or musculoskeletal or neurological conditions (myopathy or neuropathy causing muscle weakness of the upper limbs, tracheostomy and impaired mental status, rheumatism, eye disorder, dementia, and finger disorder or injury).
- •3. Subjects ineligible to use a DPI in Investigator’s opinion.
研究者
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